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Trial registered on ANZCTR


Registration number
ACTRN12620000195954
Ethics application status
Approved
Date submitted
14/02/2020
Date registered
19/02/2020
Date last updated
19/02/2020
Date data sharing statement initially provided
19/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Deferred Cord Clamping to Reduce Need for Neonatal Blood Transfusion: the Transfusions In The APTS Newborns Study (TITANS)
Scientific title
Understanding the Role of Deferred Cord Clamping in Reducing Need for Neonatal Red Cell Transfusion: what can be learned from the Australian Placental Transfusion Study? A retrospective, nested, observational study of APTS newborns
Secondary ID [1] 300464 0
None
Universal Trial Number (UTN)
Trial acronym
TITANS
Linked study record
ACTRN12610000633088 is the parent study (APTS)

Health condition
Health condition(s) or problem(s) studied:
Pre-term birth 316131 0
Condition category
Condition code
Reproductive Health and Childbirth 314422 314422 0 0
Complications of newborn

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Data from the APTS study combined with other routinely collected clinical data from APTS Australian and New Zealand sites relating to receipt of transfusion and the factors that affect risk for transfusion in preterm infants during their hospital admission after birth will be used for this study.
No additional participant contact is required for the study. Data will be collected from patient medical records.
Intervention code [1] 316762 0
Not applicable
Comparator / control treatment
Comparisons will be made between the APTS allocated groups: deferred cord clamping vs immediate cord clamping
Control group
Active

Outcomes
Primary outcome [1] 322765 0
Number of babies receiving red cell transfusion assessed through patient medical records
Timepoint [1] 322765 0
From birth to hospital discharge
Secondary outcome [1] 379647 0
Transfusions per baby assessed through patient medical records
Timepoint [1] 379647 0
From birth to hospital discharge
Secondary outcome [2] 379648 0
Cumulative transfusion volume (mL/kg) assessed through patient medical records
Timepoint [2] 379648 0
From birth to hospital discharge
Secondary outcome [3] 379649 0
Time to first transfusion assessed through patient medical records
Timepoint [3] 379649 0
From birth to first transfusion
Secondary outcome [4] 379650 0
Primary reasons for each transfusion assessed through patient medical records
Timepoint [4] 379650 0
From birth to hospital discharge

Eligibility
Key inclusion criteria
Enrolled and randomly assigned newborns (>30 weeks gestation) in Australian and New Zealand sites for the Australian Placental Transfusion Study (APTS)
Minimum age
No limit
Maximum age
30 Weeks
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
APTS participants who withdrew participation from the study

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
While APTS randomised infants to immediate or deferred cord clampling, the current study, TITANS, will look at medical data of APTS infants retrospectively. Analysis will include all randomised infants with available data and be based on intention-to-treat. Continuous data will be presented as means or medians, as appropriate. Categorical data will be presented as frequencies and percentages. Groups will be compared using chi-square tests or t-tests, as appropriate.
Mediation analysis is planned using mediator-specific and outcome models to estimate indirect effects of mediators on the relationship between timing of cord clamping and need for blood transfusion.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 15785 0
The Canberra Hospital - Garran
Recruitment hospital [2] 15786 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 15787 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [4] 15788 0
John Hunter Children's Hospital - New Lambton
Recruitment hospital [5] 15789 0
Liverpool Hospital - Liverpool
Recruitment hospital [6] 15790 0
Royal Hospital for Women - Randwick
Recruitment hospital [7] 15792 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [8] 15793 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [9] 15794 0
Mercy Hospital for Women - Heidelberg
Recruitment hospital [10] 15795 0
The Townsville Hospital - Douglas
Recruitment hospital [11] 15796 0
Mater Mother's Hospital - South Brisbane
Recruitment hospital [12] 15797 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [13] 15798 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 29220 0
2605 - Garran
Recruitment postcode(s) [2] 29221 0
2050 - Camperdown
Recruitment postcode(s) [3] 29222 0
2065 - St Leonards
Recruitment postcode(s) [4] 29223 0
2305 - New Lambton
Recruitment postcode(s) [5] 29224 0
2170 - Liverpool
Recruitment postcode(s) [6] 29225 0
2031 - Randwick
Recruitment postcode(s) [7] 29226 0
5042 - Bedford Park
Recruitment postcode(s) [8] 29227 0
3168 - Clayton
Recruitment postcode(s) [9] 29228 0
3084 - Heidelberg
Recruitment postcode(s) [10] 29229 0
4814 - Douglas
Recruitment postcode(s) [11] 29230 0
4101 - South Brisbane
Recruitment postcode(s) [12] 29231 0
4029 - Herston
Recruitment postcode(s) [13] 29232 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 22315 0
New Zealand
State/province [1] 22315 0
Auckland, Christchurch, Dunedin, Waikato, Wellington

Funding & Sponsors
Funding source category [1] 304878 0
Government body
Name [1] 304878 0
National Blood Authority
Address [1] 304878 0
Locked Bag 8430
Canberra ACT 2601
Country [1] 304878 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
University of Sydney
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 305216 0
None
Name [1] 305216 0
Address [1] 305216 0
Country [1] 305216 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305290 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 305290 0
Research Office, Level 13 Kolling Building,
Royal North Shore Hospital
St Leonards NSW 2065
Ethics committee country [1] 305290 0
Australia
Date submitted for ethics approval [1] 305290 0
Approval date [1] 305290 0
13/11/2019
Ethics approval number [1] 305290 0
2019/ETH12819
Ethics committee name [2] 305294 0
Southern Health and Disability Ethics Committee
Ethics committee address [2] 305294 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [2] 305294 0
New Zealand
Date submitted for ethics approval [2] 305294 0
Approval date [2] 305294 0
13/11/2019
Ethics approval number [2] 305294 0
19/STH/195
Ethics committee name [3] 305295 0
Mater Misericordiae Ltd Human Research Ethics Committee
Ethics committee address [3] 305295 0
Raymond Terrace,
South Brisbane Qld 4101
Ethics committee country [3] 305295 0
Australia
Date submitted for ethics approval [3] 305295 0
Approval date [3] 305295 0
20/12/2019
Ethics approval number [3] 305295 0
HREC/MML/56247

Summary
Brief summary
The Australian Placental Transfusion Study (APTS) and other studies provide strong evidence that deferring umbilical cord clamping at birth for up to a minute is a simple, safe procedure that reduces the proportion of preterm infants who need a blood transfusion by 10%. The mechanism is not fully understood – but one potential mechanism is an increased volume of transfusion of blood from the placenta to the baby after birth. Alternatively, deferred cord clamping may reduce severity of illness in the first weeks after birth. This could lead to fewer blood tests, greater tolerance of anaemia, and better opportunities for babies to make their own red cells. The Transfusions In The APTS Newborns Study (TITANS) is designed is to obtain and analyse more data about the babies in APTS to investigate the mechanism behind the reduced need for red cell transfusions, and to explore whether there are other changes in clinical care that could reduce the need for transfusion.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99890 0
Prof Helen Liley
Address 99890 0
Mater Mothers' Hospital, Mater Misericoridiae Ltd.
Aubigny 1, Mater Hill, South Brisbane
Qld 4101
Country 99890 0
Australia
Phone 99890 0
+61 7 3163 2733
Fax 99890 0
Email 99890 0
helen.liley@mater.org.au
Contact person for public queries
Name 99891 0
Dr Ava Tan-Koay
Address 99891 0
NHMRC Clinical Trials Centre, the University of Sydney
Locked bag 77, Camperdown
NSW 1450
Country 99891 0
Australia
Phone 99891 0
+61 2 9562 5046
Fax 99891 0
Email 99891 0
titans@ctc.usyd.edu.au
Contact person for scientific queries
Name 99892 0
Prof Helen Liley
Address 99892 0
Mater Mothers' Hospital, Mater Misericoridiae Ltd.
Aubigny 1, Mater Hill, South Brisbane
Qld 4101
Country 99892 0
Australia
Phone 99892 0
+61 7 3163 2733
Fax 99892 0
Email 99892 0
helen.liley@mater.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Study protocol
Ethical approval
How or where can supporting documents be obtained?
Type [1] 6790 0
Study protocol
Citation [1] 6790 0
Link [1] 6790 0
Email [1] 6790 0
titans@ctc.usyd.edu.au
Other [1] 6790 0
Attachment [1] 6790 0
Type [2] 6791 0
Ethical approval
Citation [2] 6791 0
Link [2] 6791 0
Email [2] 6791 0
titans@ctc.usyd.edu.au
Other [2] 6791 0
Attachment [2] 6791 0
Summary results
No Results